The ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial participants and patients. Acknowledging the wide and substantial impact of ICH E6, the ICH Management Committee is making available a draft, work-in-progress version of the updated principles that are currently under development by the ICH E6(R3) Expert Working Group (EWG). The principles are interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliable results of clinical trials.
Although the EWG’s work is continuing and the group is still progressing towards Step 2 of the ICH development process, the ICH Management Committee decided that sharing the draft version of the principles would facilitate transparency and common understanding. Although public comments are not requested at this time, once the updated ICH E6 Guideline achieves Step 2 of the ICH guidance development process, public input will be invited and considered.
Additionally, the E6(R3) EWG will organise on 18-19 May 2021 a global web conference to present the current draft of the GCP principles as a work in progress, with further details to be announced shortly.
The Draft Principles of ICH E6 GCP can be found on the ICH Guideline page.